TABLE 3.
AEs Seen at a Rate of ≥5% (n ≥ 5) in the Total Population and Twice as Frequently With Lithium as Placebo According to Age Strata and Treatment Group
| System Organ Class/Preferred Term | 7–11 Years of Age | 12–17 Years of Age | Total | |||
|---|---|---|---|---|---|---|
| Lithium (n = 32) | Placebo (n = 17) | Lithium (n = 21) | Placebo (n = 11) | Lithium (n = 53) | Placebo (n = 28) | |
| Eye disorders | ||||||
| Blurred vision | 4 (12.5%) | 0 | 1 (4.8%) | 0 | 5 (9.4%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 4 (12.5%) | 0 | 2 (9.5%) | 1 (9.1%) | 6 (11.3%) | 1 (3.6%) |
| Diarrhea | 10 (31.3%) | 3 (17.6%) | 5 (23.8%) | 1 (9.1%) | 15 (28.3%) | 4 (14.3%) |
| Nausea | 12 (37.5%) | 3 (17.6%) | 11 (52.4%) | 2 (18.2%) | 23 (43.4%) | 5 (17.9%) |
| Vomiting | 15 (46.9%) | 3 (17.6%) | 9 (42.9%) | 0 | 24 (45.3%) | 3 (10.7%) |
| General disorders and administration site conditions | ||||||
| Fatigue | 0 | 0 | 5 (23.8%) | 1 (9.1%) | 5 (9.4%) | 1 (3.6%) |
| Thirst | 12 (37.5%) | 0 | 3 (14.3%) | 3 (27.3%) | 15 (28.3%) | 3 (10.7%) |
| Laboratory tests | ||||||
| Blood thyroid-stimulating hormone increased | 4 (12.5%) | 0 | 5 (23.8%) | 0 | 9 (17.0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 5 (15.6%) | 1 (5.9%) | 0 | 0 | 5 (9.4%) | 1 (3.6%) |
| Nervous system disorders | ||||||
| Dizziness | 7 (21.9%) | 0 | 5 (23.8%) | 2 (18.2%) | 12 (22.6%) | 2 (7.1%) |
| Sedation | 6 (18.8%) | 0 | 0 | 0 | 6 (11.3%) | 0 |
| Tremor | 9 (28.1%) | 2 (11.8%) | 8 (38.1%) | 0 | 17 (32.1%) | 2 (7.1%) |
| Renal and urinary disorders | ||||||
| Pollakiuria (abnormally frequent urination) | 10 (31.3%) | 0 | 4 (19.0%) | 2 (18.2%) | 14 (26.4%) | 2 (7.1%) |
| Skin and subcutaneous tissue disorders | 0 | |||||
| Rash | 3 (9.4%) | 0 | 3 (14.3%) | 0 | 6 (11.3%) | 0 |